Food and Drug Administration News

Date Posted
Article Title
FDA Calls for New Warnings on Some Prostate Cancer Drugs

Hormonal meds linked to slight increase in risk of heart disease, diabetes

Pradaxa Approved to Fight Dangerous Irregular Heartbeat, Stroke

Blood thinner could be new, easier-to-manage option for patients taking warfarin, experts say

Pradaxa Approved for Atrial Fibrillation

To prevent stroke in people with abnormal heart rhythm

FDA Advisers Back Anemia Drugs for Kidney Patients

More research needed on optimum dose, despite stroke risk posed by drugs, panel members say

Baraclude Sanctioned for Severe Liver Disease

Among people with chronic hepatitis B

Botox Approved for Chronic Migraines

For people who get migraines more than 14 days per month

Front of Food Labels Should Focus on Calories, Salt, Fats: Report

Experts say this info gives consumers best guidance to cut disease risk

Vivitrol Approved to Prevent Opioid Relapse

Injected drug blocks brain's opioid receptors

Weight-Loss Drug Meridia Pulled From U.S. Market

FDA cites product's increased risk for heart attack and stroke

Infant Sleep Positioners Dangerous, U.S. Health Officials Warn

12 babies in the last 13 years suffocated in them, FDA and CPSC say in public health advisory

C-Reactive Protein Levels Vary By Race: Study

Finding could influence the use of statins to prevent heart disease, researchers suggest

Contraceptive Containing a Folate Approved

Designed to help prevent certain birth defects

FDA Restricts Access to Avandia

Citing heart risks, agency also orders review of key research on cardiovascular impact; European regulators suspend drug's sales

FDA Approves 1st Oral Drug to Reduce MS Relapses

Using pill instead of injections could boost treatment, experts say

Gilenya Approved for Relapsing MS

Oral drug designed to slow progressive disability

Consumer Activists Want Modified Salmon to Be Labeled

The animals grow twice as fast due to genetic engineering; FDA decision on approval isn't expected for months

FDA Advisers Consider Approval of Genetically Modified Salmon

The animals grow twice as fast due to genetic engineering, but critics fear risks to health and the environment

FDA Advisers Weigh Approval of Genetically Modified Salmon

The animals grow twice as fast due to genetic engineering, but critics fear risks to health and the environment

Three Cardiac Resynchronization Defibrillators Approved for New Use

Only for certain heart failure patients, agency notes

FDA Advisers Divided on Whether to Ban Diet Drug Meridia

Signs of heart and stroke risks prompt some panelists to call for new warnings and restricted distribution

Krystexxa Approved for Gout

For adults who can't use other therapies

FDA Panel to Mull Ban on Diet Drug Meridia

Withdrawal of the drug, which may raise heart risks, is an option, agency says

Chemical Poisoning Treatment Approved for Children

Pralidoxime chloride sanctioned decades ago for adults

FDA Sends Warning to E-Cigarette Distributors

Agency cites false claims, poor manufacturing processes

Eggs Being Produced by Recall Farms Safe, if Pasteurized, Experts Say

Treated eggs can be used in products such as salad dressings, cookie dough and cake mixes

Are The Eggs in Your Fridge Safe to Eat?

Experts tell you what you need to know in the wake of a massive recall

FDA Chief Says More Egg Recalls Possible

Nearly 2,000 reports of salmonella infections in people in about 22 states

2nd Egg Recall Linked to Salmonella Under Way

Producer says there have been laboratory-confirmed cases of Salmonella enteritidis

2nd Egg Recall Linked to Salmonella Under Way

Producer says there have been laboratory-confirmed cases of Salmonella enteritidis

Nationwide Recall of Eggs Linked to Salmonella Expanded

More than 250 people sickened by germ as Iowa company recalls 380 million eggs

Ella Emergency Contraceptive Approved

Intended to inhibit or delay ovulation

FDA Approves Emergency Contraceptive

Called 'ella,' drug delays ovulation, but opponents say it's another abortion pill

Food Labels Lead to Healthy Food Choices

Label readers consume fewer calories, less saturated fat, cholesterol, sodium, sugars, study finds

Flu Vaccine for Upcoming Season Approved

Protects against three strains predicted to be most prevalent

Experts Support FDA Panel's Backing of New Blood Thinner

Brilinta, which got nod from agency advisors Wednesday, would be welcome option, docs say

H1N1 Protection in Coming Season's Flu Vaccines: FDA

Just one shot should shield against multiple strains, agency says

Cuvposa Approved for Chronic Drooling in Children

Primarily those with neurological disorders

FDA Cites Its Food Safety Web Site

More than 100 problems identified so far, agency says

Combination Drug Approved for High Blood Pressure

Tribenzor sanctioned for those who don't respond to other drugs

FDA Panels Reject Plan to Curb Opioid Painkiller Abuse

Stumbling block was lack of mandatory training for prescribing doctors, official says

Generic Lovenox Approved for Deep Vein Thrombosis

A condition that could cause deadly blood clots

FDA Puts Partial Hold on Avandia Safety Study

Enrollment in TIDE trial suspended after agency rules diabetes drug has heart risks

Diabetics Urged to Confer With Their Doctor About Avandia Use

Health risks posed by an unauthorized change of medications could be great, experts say

Avandia Raises Heart Risk But Should Stay on Market, FDA Panel Finds

Experts vote for tightened controls or restricted sales on diabetes drug

New Pill Found to Cut Weight With Few Side Effects: Study

Lorcaserin one of three new anti-obesity medications up for review by the FDA

FDA Panel Seems Skeptical Over Key Avandia Data

Recent allegations of suppressed or manipulated findings by diabetes drug's maker may be having an impact

FDA Reviewer Questions Results of Key Avandia Trial

Ahead of crucial advisory panel meeting next week, official cites 'mishandling' of data for diabetes drug

FDA Advisory Panel Decision on Avandia Looms

Experts meet next week to pore over study data on controversial diabetes drug

'Miniature Telescope' for Eye Approved for Macular Degeneration

Implanted device replaces eye's natural lens

Generic Effexor XR Approved

To treat major depressive disorder